Wang Webinar Nov 2015 - LinkedIn
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Copyright © 2015 Jian Wang, PhD CEO Next Generation Biobanking Webinar recording: https://youtu.be/wvsyL9PUZRg
Transcript of Wang Webinar Nov 2015 - LinkedIn
Copyright © 2015
Jian Wang, PhD CEO
Next Generation Biobanking
Webinar recording: https://youtu.be/wvsyL9PUZRg
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Biobanking Used to be Simple…
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HIGH QUALITY HIGHLY ANNOTATED
CONSENTED PATIENT LINKED
SAMPLE
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The Critical Biobanking Challenges
Biobanks
Expectation of driving the
science
Externalization &
Collaboration
Increased regulatory
scrutiny
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Data Management
& Exploration
Operational Biobanking
Virtual Biobanking;
Clinical Trial
Sample / Consent Tracking
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Sponsor
Clinical Trial Sample / Consent Tracking
Site
Central Lab
Site
Site
Testing Lab
Testing Lab
Storage Testing Lab
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Site Sponsor
Vendor / CRO
Sample Shipment
Consent Deviation / Sample Destruction
(e.g. patient withdraw)
Sample Destruction
(patient withdraw or sponsor policy)
Patient Consent
Trial Setup & Sample Logistics
Sample Collection Specification
Sample Inventory
Consent Reconciliation
consent patients &
acquire samples
Sample Tracking Use Case
Sample Shipment
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Support Virtual Biobank
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Conceptual Framework
Plan
Reality Consent
Analysis request Destruction workflow Operational reporting
Sample/consent reconciliation …
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https://image-store.slidesharecdn.com/2eb15037-d07b-4f31-b93d-043a157b5814-original.jpeg
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Typical Process
• Study Planning • Patients, visits, consents, … • Sample collection, routing, …
• Patient Enrollment • Actual patients • “Expected” samples for patients
• Patient Consent • Consent on samples • Consent reconciliation
• Sample Intake • Receive samples • Store samples
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Typical Process
• Sample Reconciliation • Reconciliation per study plan • Data harmonization across all players in the ecosystem
• Sample Request • Request samples for research use • With proper approval processes
• Request Fulfillment • Actually fulfill the sample request • Potentially across multiple facilities
• Sample Destruction • End of life, Consent withdraw, …
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Example Data Sources
•Study Protocol & Lab Manual: Sample collection/routing plans
•Informed Consent Document: Consent parameters
•IxRS: Subject Info, SID
•EDC: Visit, Subject Consent
•Central Lab (or site): First data on samples, derivative samples,
shipment/receiving, patient info
•Testing lab: derivative samples, shipment/receiving
•Storage: derivative samples, shipment/receiving, future use
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Operational Biobank
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Research BioBank 1B Pathology Sample A597
(text-only label)
Sample Inventory & Operations
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Platform Advantage
Operational
• Biobanking workflows • Access Controls • Annotations • More…
Decision Support
• Scientific insights • Ad hoc query • Hypotheses • Reporting
Unique out-of-the box integration of the operational with decision
support
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Exploration Acquisition Analysis Analysis
Data Harmonization, Reporting & Exploration
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Qiagram Enables Data Exploration
Data Managers
Query data directly by themselves
Researchers
SELECT DISTINCT PATIENT_ID, SAMPLE_ID, SAMPLE_NAME FROM SAMPLE_INVENTORY S INNER JOIN PATIENTS P ON S.PATIENT_ID = P.PATIENT_ID INNER JOIN DIAGNOSIS D ON S.PATIENT_ID = D.PATIENT_ID INNER JOIN MEDICATIONS M ON S.PATIENT_ID = M.PATIENT_ID INNER JOIN BIOMARKERS B ON S.PATIENT_ID = B.PATIENT_ID WHERE D.DIAGNOSIS_NAME = ‘LUNG CANCER’ AND M.MEDICATION_GENERIC_NAME = ‘CETUXIMAB’ AND B.BIOMARKER_NAME = ‘EGFR’ AND B.OBSERVATION = 1 ORDER BY PATIENT_ID, SAMPLE_NAME
Both now speak the same language
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Clinical Trial Sample Tracking – Can You Answer These Questions?
Study-specific reports (on-going studies): 1. Planned sample collection report 2. Actual sample collection report 3. Reconciliation of planned vs. actual sample collection
• What samples are missing (or late) for a given visit? • Which patients have complete set of samples collected for a
given (set of) visits and sample types? 4. Anticipated upcoming sample collections (based on Subject
enrollment and sample collection plan) 5. Sample allowable use (consent) report
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Clinical Trial Sample Tracking – Can You Answer These Questions?
6. Sample Chain of Custody (CoC) report • Sample location • Sample status • Reconciliation of sample location with routing plan • Expected vs actual timing of CoC events
7. Study Closeout Report • Number of samples collected, reconciled: Do we have all the
samples for all the patients in the study? • Subject participation rate (for optional collections)
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Clinical Trial Sample Tracking – Can You Answer These Questions?
Cross-Study Reports:
1. Sample collection performance metrics • By Facility across studies • By Country • By Study • By Therapeutic area
2. Sample expiration report (based on consent and other parameters)
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Example (Mock) Reconciliation Report
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For Further Information
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Contact:
Jian Wang, Ph.D.
CEO
BioFortis, Inc.
10320 Little Patuxent Parkway, Suite 410
Columbia, MD 21044
